Kornimate/medical-research-clean huggingface dataset:
bioequivalence study of rotigotine transdermal patch with two different formulations in healthy japanese subjects

Conditions: Healthy Volunteers

Summary: to investigate and compare the drug amount delivered to the body after each single administration of rotigotine patch with 2 different formulations in healthy japanese subjects.


Eligibility criteria:
inclusion criteria: * healthy japanese male and female volunteers with the age between 20 and 55 years old exclusion criteria: * subject has participated or is participating in any other clinical studies of investigational drug or another investigational medical product (imp) within the last 3 months * subject is not healthy (eg, taking any drug treatments, excessive amount of alcohol, cigarettes, having any medical or emotional/psychological problems, a drug/alcohol abuse, having abnormal safety parameters) * subject has a qtcb (qt interval corrected for heart rate \[hr\] using bazett´s formula) interval of ≥ 430 ms (≥ 450 ms for females) or any other clinically relevant finding in electrocardiogram (ecg) at the eligibility assessment (ea) * subject is having clinically relevant allergy or clinically relevant drug hypersensitivity to any components of the investigational medical product (imp), or/and having an atopic or eczematous dermatitis, psoriasis and/or active skin disease * subject has a recent history (within 2 years) of chronic alcohol or drug abuse and has a history of significant skin hypersensitivity to transdermal products, and of an atopic or eczematous dermatitis, psoriasis, and/or active skin disease and have a history of suicide attempt, epilepsy and/or seizures * subject has made a blood donation or a comparable blood loss within the last 3 months prior to the eligibility assessment (ea) * subject is pregnant or nursing

Keywords: rotigotine neupro® transdermal patch bioequivalence
lipid profile response to electroacupuncture stimulation in non alcoholic fatty liver patients

Conditions: Fatty Liver , Electroacupuncture, Lipid Profile

Summary: sixty female patients suffering from non-alcoholic fatty liver disease were randomly divided into two equal groups group 1 received electroacupuncture stimulation for 6 weeks at special points of stimulation. group 2 was a control group that received nothing without any change in lifestyle and we assed the response of lipid profile post-treatment protocol in both groupes


Eligibility criteria:
inclusion criteria: non alcoholic fatty liver bmi 30-40 exclusion criteria: * patients with: (hepatitis c \& b any form of seizure
evaluation of the ability to detect bowel gas during laparoscopic surgery

Conditions: Intestinal Perforation

Summary: this study will determine the ability of the device to draw a small amount of gas from an insufflated abdomen during laparoscopic surgery and accurately detect if gaseous content from the bowel is present.

undetected bowel perforation is a rare but dangerous complication of laparoscopic surgery. if the injury is not detected and treated at the time of the surgical procedure, the patient can suffer sever complications including septic shock and eventually death. our goal is to test a novel device that can detect bowel gas leakage from a perforation and alert the surgeon during the operation by evaluating the gases present in the insufflated abdomen during surgery. during laparoscopic surgery, carbon dioxide in inserted in the abdominal cavity in order to perform the operation. this is dynamic process as insufflation is a constant during the entire procedure to maintain a constant pressure and compensate small leaks due to the insertion and retrieval of instruments. this study will determine the ability of device to be attached to a standard veress needle or trocar during the operation and periodically draw a small amount of gas from the abdomen to evaluate the gas and accurately detect gaseous content from the bowel. before the device can be used to detect bowel perforations, first we must ensure that it can accurately detect bowel gas in an insufflated abdomen.

Eligibility criteria:
inclusion criteria: 1. age 18 - 60 years old with the diagnosis of morbid obesity, who qualifies for laparoscopic gastric bypass surgical therapy, and has elected to undergo laparoscopic gastric bypass surgery. 2. receiving care in the stanford hospital general surgery bariatric surgery clinic under the care of dr. dan azagury 3. the patient is scheduled for laparoscopic roux en y gastric bypass surgery, with dr. azagury. 4. willing and cognitively able to sign informed consent. exclusion criteria: 1. lack of or inability to provide informed consent. 2. less than 18 years of age or greater than 60 years of age 3. planned deviation from the standard laparoscopic gastric bypass operation 4. conversion intra-operatively from a laparoscopic gastric bypass to an alternative laparoscopic surgical operation or to an open gastric bypass operation. 5. enrollment in another device or drug study that may confound results.

Keywords: intestinal perforation bariatric surgery gastric bypass gastric perforation colonic perforation
"monoclonal antibodies for treatment of multiple myeloma. emphasis on the cd38 antibody daratumumab "

Conditions: Multiple Myeloma

Summary: daratumumab is a new treatment for patients with myeloma. while many patients benefit from this treatment some do not and the mechanism(s) of failure are poorly understood. this study aims to clarify aspects of resistance to treatment with daratumumab in order to improve patient outcomes in the future.

the effector mechanisms of daratumumab have been extensively studied in vitro, but the in vivo correlates and key determinants of success or failure when daratumumab is used alone or in combination with lenalidomide for treatment of patients with myeloma have not been clarified. there is potentially a wide spectrum of factors that may influence the quality and duration of response following treatment with daratumumab. the integrity of the patient's immune system may be important. prior lines of chemotherapy or the myeloma disease itself may impair humural (i.e. complement) or cellular (i.e. adcc) effector mechanisms that are of importance for the response to daratumumab. also intrinsic properties of the tumor cells or interactions between myeloma cells and the bone marrow microenvironment could make the myeloma cells refractory to daratumumab. a better understanding of these variables may enable us to improve the quality and duration of daratumumab-induced responses and make daratumumab-based therapies more effective in the near future.

Eligibility criteria:
inclusion criteria: * accepted for a clinical trial with daratumumab for myeloma exclusion criteria: * none

Keywords: myeloma monoclonal antibody daratumumab
controlling antimicrobial use through reducing unnecessary treatment of catheter associated urinary tract infections

Conditions: Catheter-Related Infections

Summary: hypothesis: a short course (3-5 days) of antibiotic therapy (experimental arm) is as safe and effective as a long course of antibiotic therapy for the treatment of catheter-associated urinary tract infections.


Eligibility criteria:
inclusion criteria: 1. inpatients ≥ 21 years old. 2. presence of indwelling urinary catheter at the time of urine culture for ≥2days. 3. fever \>38°c. 4. a urine specimen sent to the hospital microbiological laboratory for culture. 5. an antibiotic order for presumed symptomatic catheter associated urinary tract infection. exclusion criteria: 1. persistent fever \>38°c for more than 24 hours, or any fever \>38.9°c. 2. haemodynamic instability, defined as: * requirement for intravenous vasopressor agents * systolic blood pressure \<90 mmhg * acute hypotensive event with drop in systolic blood pressure of \>30 mmhg or diastolic blood pressure of \>20 mmhg 3. the following laboratory values within the previous 48 hours (if available): * white blood cell count\>15 or \<4 x10\^9/l. * procalcitonin\>0.25ug/ml * c reactive protein \>100mg/ml * an increase in the serum creatinine of more than 50% from baseline 4. new requirement for oxygen supplement. 5. current admission to a high dependency unit or icu. 6. radiological evidence of an upper urinary tract infection 7. flank pain or tenderness, suggesting an upper urinary tract infection 8. urologic surgical procedure within the previous 72 hours 9. known structural genitourinary abnormalities including: * nephrostomy tubes * tumours of the urinary tract * ureteric stenting * ureteric strictures * urolithiasis 10. bloodstream or other significant infection suspected at any site other than the catheterized urinary tract. 11. received antibiotics for more than 48 hours prior to randomization. 12. positive urinary culture with organism resistant to all the investigational antibiotics in the week prior to randomisation. 13. hypersensitivity to ciprofloxacin, cotrimoxazole and amoxicillin-clavulanate. 14. pregnancy.

Keywords: catheter-associated urinary tract infections antimicrobial stewardship short-course antimicrobials
the impact of preemptive epidural analgesia on acute postoperative pain in pediatric orthopedic surgery

Conditions: Pediatric Surgical Patients; Preemptive Epidural Analgesia

Summary: management of postoperative pain is critical in the pediatric patients, however, safe and effective analgesia for pediatric surgical patients remains a challenge. preemptive analgesia is based on preventing a prolonged change in central nervous system function by blocking afferent input before the surgical stimulation may evoke central sensitization and aggravate amplification and prolongation of postoperative pain. however, the clinical efficacy of preemptive analgesia is still controversial. in this study, the investigators aim to assess the impact of preemptive epidural analgesia on postoperative pain in pediatric patients for corrective osteotomy of the lower extremities expecting severe postoperative pain.


Eligibility criteria:
inclusion criteria: * pediatric patients (3-12 years of age) scheduled for corrective osteotomy of the lower extremities * asa class i and ii exclusion criteria: * coagulopathy * neurological disease * allergy to local anesthetics or contraindication to use of ropivacaine * infection at the site of epidural catheter insertion

Keywords: child analgesia epidural pain postoperative orthopedics
effect of transcranial direct-current stimulation in attentional performance and pain in patients with fibromyalgia

Conditions: Fibromyalgia

Summary: tdcs can modify the attentional response of patients with fibromyalgia. methods: this study deals with a randomized, blind, crossover, controlled tdcs-sham. the sample will consist of 40 patients, divided into two groups with sham interventions and active crossover.

check that the tdcs can modify the attentional response of patients with fibromyalgia. methods: this study deals with a randomized, blind, crossover, controlled tdcs-sham. the sample will consist of 40 patients, divided into two groups with sham interventions and active crossover. patients answer the questionnaires in order to verify the psychological factors and clinical. will use the impact of fibromyalgia (qif), pittsburgh sleep questionnaire, conditioned pain modulation (cpm), beck depression scale ii, catastrophic scale , go nogo test, attention network task (ant) to verify the ability attentional as well as to verify the near-infrared spectroscopy (nirs) brain oxygenation. they will be used before, during and after the intervention with tdcs. intervention with tdcs or sham will be held in a single session. expected results: it is expected that fibromyalgia patients undergoing tdcs present, after the intervention, improved attention capacity .

Eligibility criteria:
inclusion criteria: * female patients, literate, right-handed, 18 to 65 years of age, who meet the criteria of the american college of rheumatology (acr) for fibromyalgia. exclusion criteria: * pregnant women * contraindications to tdcs * metal implant in the brain * history of alcohol or drug abuse in the last six months * suffer from severe depression (score\> 30 on the beck depression inventory) * history of neurological disorders * unexplained fainting * self-reports of head injury or momentary loss of awareness * neurosurgery. * will also be excluded patients who have decompensated systemic diseases and / or chronic inflammatory diseases (ex .: lupus, rheumatoid arthritis).

Keywords: fibromyalgia transcranial direct current stimulation
clinical nursing practice supported by results of research: mixed-method study

Conditions: Oncology

Summary: the purpose of the study is to assess the attitudes and the use of research by nurses at the irccs-cro aviano. furthermore, it will make it possible to identify attitudes towards the use/non-use of research results, specific training needs and targeted interventions to ensure adequate care for cancer patients along the disease course, derived from a constant updating of nursing skills. the study will involve nurses working in different care settings of the institute and some patients who will be able to express their care needs and research priorities, making a direct contribution towards development of care centred on the health needs, preferences and values of the cancer patients.


Eligibility criteria:
inclusion criteria for nurses: * all nurses employed at irccs-cro aviano under fixed-term and permanent contract on 15 september 2023; * nursing activities in the departments of medical and surgical oncology and high technologies; * full-time and part-time employment contract; * signature of consent for participation in the study and processing of personal data (privacy). patient inclusion criteria: * patients admitted to the institution as in-patients; * age ≥ 18 years; * signature of consent for participation in the study and processing of personal data (privacy); * good understanding of the italian language. exclusion criteria for nurses: - lack of willingness/interest in participating in the study and signing the consent. patient exclusion criteria: * day-hospital patients; * age \< 18 years; * diagnosis of cognitive dysfunction or psychiatric disorders; * difficulties in understanding the italian language.
an absolute bioavailability study in healthy participants comparing oral to intravenous administration of gdc-0973 (cobimetinib)

Conditions: Healthy Volunteers

Summary: the primary objective of part 1 of this study is to evaluate the safety and tolerability of the intravenous (iv) dose of gdc-0973. the primary objectives of part 2 of this study are to evaluate the absolute bioavailability of gdc-0973 and to evaluate the pharmacokinetic (pk) of gdc-0973 following iv and oral administration. the secondary objective of part 2 of this study is to evaluate the safety of gdc-0973 administered orally and intravenously.


Eligibility criteria:
inclusion criteria * within body mass index range 18.5 to 29.9 kilograms per square meter (kg/m\^2) * in good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ecg), and vital signs * clinical laboratory evaluations within the reference range for the test laboratory * negative test for selected drugs of abuse at screening and at each check-in * negative hepatitis panel and anti-hepatitis c virus and negative human immunodeficiency virus (hiv) antibody screens * healthy males and females of non-child-bearing potential or who agree to use effective contraception exclusion criteria * significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder * history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance * history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs except that appendectomy, hernia repair, and cholecystectomy will be allowed * history or presence of an abnormal ecg * history of alcoholism or drug addiction prior to period 1 check-in * use of any tobacco-containing or nicotine-containing products prior to period 1 check-in * participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 28 days or 5 half-lives, whichever is longer, prior to period 1 check-in * use of any prescription medications/products, including proton pump inhibitors, within 14 days prior to period 1 check-in * poor peripheral venous access * any acute or chronic condition that would limit the participants ability to complete and/or participate in this clinical study * female participant is pregnant, lactating, or breastfeeding * predisposing factors to retinal vein occlusion (rvo)
a study of diffusing alpha radiation therapy for patients with breast carcinoma in frail or elderly patients.

Conditions: Breast Cancer; Recurrent Breast Cancer; Breast Carcinoma

Summary: a unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of newly diagnosed or recurrent breast carcinoma in frail or elderly patients.

this is a prospective open label single arm multi-center interventional study. the study is designed to evaluate the feasibility and safety of dart seeds for the treatment of newly diagnosed or recurrent breast carcinoma in frail or elderly patients. the study will be comprised of a screening period, dart insertion visit, acute follow-up phase of 4- 8 weeks and a long-term follow up phase of 24 months. the total duration of the study will be 24 months from the dart insertion procedure. a total of 10 subjects will be enrolled from all breast cancer subtypes (hr+/her-2-, hr+/her-2+, hr-/her-2-, and hr-/her-2-.). no formal interim analysis is planned for this study. eligible patients who meet inclusion/exclusion criteria (as assessed during the screening period) will be invited to the site for the procedure of dart seeds insertion. the patients will be monitored for a period of 24 months post insertion

Eligibility criteria:
inclusion criteria: * histologically confirmed invasive breast tumor with no involvement of skin within 12 months. * tumor size ≤ 4 centimeters in the longest diameter. * tumor is not deemed as resectable with radical surgery or the patient does not wish to go through surgery * de-novo or recurrent lesions. * single lesion per quadrant per subject. * targeted lesion must be technically amenable for complete coverage (including margins) by the dart seeds. * interstitial implant indication validated by multidisciplinary team. * ecog performance status ≤3. * life expectancy ≥12 months. * women age ≥65 or younger if unfit for standard of care. * willing and have the ability to provide signed informed consent. * blood tests values: * leucocytes ≥3000mm3, * absolute neutrophil count ≥1500mm3, * platelets ≥100,000 mm3, * total bilirubin ≤ 1.5xuln, * ast, sgot, sgpt ≤2.5xuln, if alkaline phosphatase ≤ 4xuln, then transaminases are normal. * creatinine ≤ 2.0xuln. * inr or prothrombin time ≤1.5xuln exclusion criteria: * t4 category with skin involvement. * ductal carcinoma in situ. * inflammatory breast carcinoma. * longest tumor diameter \>4 cm. * patients with prior radiation to the same area within the past 6 months. * has a known additional malignancy that is progressing or requires active treatment. * patients undergoing immunosuppressive and/or systemic corticosteroid treatment except for steroid inhalations for treatment of asthma or lung disease * subjects not willing to sign an informed consent.

Keywords: alpha radiation breast cancer newly diagnosed breast carcinoma breast carcinoma
intraosseous basivertebral nerve ablation for treatment of chronic low back pain

Conditions: Chronic Low Back Pain

Summary: objective of study is to evaluate the procedural success rate, clinical effectiveness, and heath-economic profile using the intercept intraosseous nerve ablation system in adult subjects with chronic low back pain in the post-market setting

this is a prospective, open-label, single-arm, single-center study. there is no randomization or blinding. subjects will receive the intercept system procedure to treat one or two motion segments at l3/l4, l4/l5, or l5/s1 as identified by modic type 1 or 2 changes.

Eligibility criteria:
inclusion criteria: * skeletally mature subjects age 25-70 years, inclusive * chronic lower back pain for at least six months * failure to respond to at least six months of non-operative conservative management * oswestry disability index (odi) at time of evaluation of at least 30 points * modic changes (type 1 or 2) in at least one vertebral endplate, at one or more levels from l3 to s1 exclusion criteria: * radicular pain by history or evidence of pain neurological deficit within the past one year. * previous surgery performed on the lumbar spine * current or history of symptomatic spinal stenosis * current or history of osteoporotic or tumor-related vertebral body compression fracture * current or history of vertebral cancer or spinal metastasis * current or history of spinal infection * metabolic bone disease * bmi greater or equal to 40 * any radiographic evidence of other important back pathology * mri evidence of modic changes, type 1 or 2 at greater than 3 vertebral bodies or at non-consecutive levels, or at vertebral bodies other than l3 to s1 * any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain * subjects who are bed bound * demonstrates 3 or more waddell's signs of inorganic behavior * any evidence of current systemic infection